OBJECTIVE: To explore the clinical efficacy and safety of modified Shengxian decoction in adjunctive treatment of acute episode of chronic pulmonary heart disease (CHPD). METHODS: 208 patients with acute episode of CHPD were divided into observation group and control group with 104 cases in each group according to random number table method. Control group was given comprehensive treatment of western medicine, including oxygen inhalation, anti-infective therapy, eliminating phlegm, relieving asthma, correcting respiratory and heart failure, etc. Observation group was additionally given modified Shengxian decoction, one dose a day, for 7 d, on the basis of control group. The cardiac and pulmonary function, clinical symptoms, sign score and total score were observed in 2 groups before treatment and after treatment. Clinical efficacy and the occurrence of ADR were compared between 2 groups. RESULTS: There was no statistical significance in FEV1/predictive value and FEV1/FVC between 2 groups before treatment (P>0.05); 7 d after treatment, cardiac functional grading of 2 groups were improved significantly, and FEV1/predictive value and FEV1/FVC were increased significantly; the observation group was significantly better than the control group, with statistical significance (P<0.05). There was no statistical significance in clinical symptoms and signs, total score between 2 groups before treatment and 3 d after treatment (P>0.05); 7 d after treatment, above score of observation group were significantly lower than that of control group, with statistical significance (P<0.05). Total effective rate of observation group (98.1%) was significantly higher than that of control group (90.4%), with statistical significance (P<0.05). No obvious ADR was found in 2 groups. CONCLUSIONS: The adjunctive therapy with modified Shengxian decoction is significantly effective for acute episode of CHPD, and can improve the cardiac and pulmonary function and clinical manifestations with good safety.